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Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

Cohort of Patients With Pelvic Gynecological Cancer: Constitution of a Collection of Biological Samples With Radioclinical Characterization

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03622983
Acronym
PELVIMASS2
Enrollment
500
Registered
2018-08-09
Start date
2017-05-01
Completion date
2037-08-31
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Pelvic Neoplasms

Brief summary

The management of pelvic gynecological cancers (PGC) is based on the determination of extension to guide treatments. The biology of the CGP is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing ovarian tumors can select patients who can benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify the factors predictive of recurrence of these cancers. The results obtained are very promising. This study will permit to collect biological samples and detailed clinical data that would allow to test hypotheses and develop a personalized medicine based on clinical and biological characteristics of patients.

Detailed description

The management of pelvic gynecological cancers (PGC) is based on the determination of the extension in order to guide the treatments. The biology of PGC is constantly evolving and personalized medicine adapted to this biology is currently in full development. For example, sequencing of ovarian tumors allows selection of patients who may benefit from anti-PARP therapy. There is therefore a need for patients to have biological samples of their tumor. Various studies on ovarian, endometrial and cervical cancer have sought to identify factors that predict recurrence of these cancers. The results have obtained are very promising, but if coordinator team have at our disposal fundamental and translational data related to the prognosis of PGCs, the coordinator team lack access to a biological collection of these cancers that would allow us to test our hypotheses and to develop personalized medicine related to the clinico-biological characteristics of the patients. Endometriosis is the 1st cause of chronic pelvic pain (25-40% of women suffering during sexual intercourse) and represents the 1st cause of school and work absenteeism. Unfortunately, it is under-diagnosed and too often inappropriately managed. It is considered that 10 to 15% of the female population of reproductive age has endometriosis. This incidence reaches 50% in women with infertility. There are many similarities between deep endometriosis and pelvic cancers, whether on a physiopathological, epidemiological or clinical level. There are therefore many similarities in the surgical management as well as in the research strategies.

Interventions

OTHERcollection of sample and data

Recovery of surgical waste during surgery planned in the current care and clinical data collection

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of pelvic gynecological cancer posed on initial histological analysis or during recurrence; * Or diagnosis of endometriosis on histology or imaging * Age ≥ 18 years; * Affiliation to the general social security scheme; * Consent signed.

Exclusion criteria

* Refusal of the patient; * Non-affiliation to the general social security scheme.

Design outcomes

Primary

MeasureTime frame
circulating tumor and DNA2 years
Endometriosis tumor and DNA2 years

Secondary

MeasureTime frame
circulating tumor DNA5 years
circulating Micro RNA2 years
circulating cytokines2 years
Tumoral DNAday of surgery

Countries

France

Contacts

Primary ContactCyril Touboul
cyril.touboul@gmail.com0156017000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026